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Terconazole

Terconazole is an azole antifungal used as a vaginal cream or vaginal suppository to treat vulvovaginal candidiasis, a vaginal yeast infection.

Brand name Terconazole Vaginal Cream 0.8%
Drug class Azole Antifungal
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 27, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 14 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026
Terconazole at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Terconazole is a prescription azole antifungal, used as a vaginal cream or insert for three nights to treat a yeast infection (vulvovaginal candidiasis), and works by blocking the yeast from making ergosterol, a building block of its cell wall; on the market since the late 1980s and available as a generic, it is a prescription alternative to over-the-counter yeast creams. Most people tolerate it well; headache, period cramps, and genital burning or itching are what people notice most. Stop it and get help right away for signs of a serious allergic or skin reaction (trouble breathing, blistering or peeling skin), or for fever, chills or flu-like symptoms with the cream.

Clinical pearls

  • Insert it at bedtime so it stays in place overnight, and finish all three nights even if itching eases after the first.
  • It works only on Candida yeast, so a lab test (a KOH smear or culture) should confirm the diagnosis first.
  • Birth control pills do not weaken terconazole, and the cream did not change hormone levels in women on low-dose pills.
  • If you have reacted to another azole antifungal before, or symptoms return, get checked before using another course.
How you get itPrescription only
Comes asVaginal cream or gel, Vaginal insert
Earliest FDA record1987
Companies listing it with the FDA6
FDA label last updatedJan 28, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Terconazole, written from its FDA label.

What Terconazole is used for

▾

Terconazole is used for one condition across its supported products.

  • Terconazole vaginal cream: local treatment of vulvovaginal candidiasis (a vaginal yeast infection).
  • Terconazole vaginal suppositories: local treatment of vulvovaginal candidiasis.
  • Both work only for infections caused by Candida, so lab tests (KOH smears and/or cultures) should confirm the diagnosis.

How Terconazole works

▾

Terconazole is an azole antifungal. It blocks a fungal enzyme needed to turn lanosterol into ergosterol, which fungi need for their cell wall. As ergosterol is lost, the yeast cannot grow normally.

Human cells are less sensitive to this effect. Terconazole also does not affect the lactobacilli, the helpful bacteria normally found in the vagina.

Terconazole dosage

▾

Both forms are used in the vagina once a day at bedtime for three days in a row.

  • Terconazole vaginal cream: one applicator full each night. Not for the mouth or eyes.
  • Terconazole vaginal suppositories: one suppository each night. Menstruation does not reduce its effect.

Follow your prescriber's directions and the product label.

Dosing details from the FDA-approved label

From the Terconazole prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Terconazole Vaginal Cream (0.8%)
    • One applicator full (5 grams of cream containing 40 mg terconazole) administered intravaginally once daily at bedtime for three consecutive days
    • Not for oral or ophthalmic use
  • Terconazole Vaginal Suppository
    • One suppository (80 mg terconazole) administered intravaginally once daily at bedtime for three consecutive days
    • Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect is not affected by menstruation.
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The recommended dose is one applicator full of Terconazole Vaginal Cream (5 grams of cream containing 40 mg terconazole) administered intravaginally once daily at bedtime for three consecutive days. Terconazole Vaginal Cream is not for oral or ophthalmic use. • One full applicator (5 grams) of Terconazole Vaginal Cream administered intravaginally once daily at bedtime for three (3) consecutive days. ( 2 ) • Not for oral or ophthalmic use. ( 2 )

Read the full Dosage and Administration section on DailyMed →

Terconazole side effects

▾

The most common side effects are:

Common side effects

  • Headache
  • Painful periods (dysmenorrhea)
  • Genital burning and itching
  • Abdominal pain
  • Fever (less common)

When to get medical help

  • Stop the cream and call your doctor if you develop skin irritation, fever, chills or flu-like symptoms.
  • Stop the suppositories and get emergency help for signs of a severe allergic reaction (anaphylaxis).
  • Stop the suppositories and get urgent help for a severe skin reaction called toxic epidermal necrolysis (widespread painful skin peeling and blistering).
  • Call your doctor if symptoms do not improve before using another course.

Terconazole warnings and precautions

▾
  • Anaphylaxis and toxic epidermal necrolysis have been reported. Stop the suppositories if either occurs.
  • With the cream, stop and do not retreat if skin irritation, fever, chills or flu-like symptoms occur.
  • Before another course, the diagnosis should be reconfirmed and other causes of vaginal infection ruled out.
  • Patients with a history of allergy to azole antifungals should be monitored.

Terconazole interactions

▾

The label notes little in the way of interactions.

  • Birth control pills: do not change how well terconazole works.
  • Hormone levels: estradiol and progesterone did not differ significantly when the vaginal cream was used with a low-dose birth control pill.

Interactions listed in the FDA-approved label

From the Terconazole prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Oral contraceptives: The therapeutic effect of terconazole is not affected by oral contraceptive usage; levels of estradiol and progesterone did not differ significantly when 0.8% terconazole vaginal cream was administered to healthy female volunteers established on a low dose oral contraceptive.
Read the label’s full interactions text

Drug Interactions - The therapeutic effect of terconazole is not affected by oral contraceptive usage. The levels of estradiol and progesterone did not differ significantly when 0.8% terconazole vaginal cream was administered to healthy female volunteers established on a low dose oral contraceptive.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Terconazole

▾
  • Do not use the cream if you are allergic to terconazole or any of its ingredients.
  • Tell your doctor about any past allergy to azole antifungals.
  • Pregnancy: no human data on the cream are available to assess risk.
  • Breastfeeding: no data on milk transfer. Weigh benefits and risks with your doctor.
  • Children: safety and effectiveness of the cream have not been established.
  • Adults 65 and older: not enough studied to know if response differs.

Terconazole overdose

▾

If the cream or suppository is swallowed, supportive and symptom-based care is recommended. If the cream gets in the eyes, rinse with clean water or saline and seek medical attention if symptoms persist.

What Terconazole does in the body

▾

Terconazole shows antifungal activity in the lab against Candida albicans and other Candida species. It does not affect most of the beneficial lactobacilli normally found in the vagina.

How your body processes Terconazole

▾

Most of the drug stays in the vagina after use. Roughly 10% is absorbed into the bloodstream over 7 days, with blood levels peaking about 5 to 10 hours after use. Absorbed terconazole is extensively broken down by the body and is about 95% bound to proteins in the blood. Its half-life is about 6.4 to 8.5 hours, and levels do not build up meaningfully with repeated use.

How to store Terconazole

▾

Store at 20° to 25°C (68° to 77°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

20

Supplements & herbs that interact with Terconazole

20 supplements and herbal products have documented interactions with Terconazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 12
Every supplement checked against Terconazole — ranked by severity The full interaction hub: 1 major · 7 moderate · 12 minor · every one linked to its full report. Check Terconazole against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Terconazole: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Terconazole — the kind of thing our pharmacy team would talk through with you at the counter.

What is terconazole for?

▾
It treats vaginal yeast infections, called vulvovaginal candidiasis, caused by Candida. It only works on that type of infection, so your doctor may confirm the diagnosis with lab tests first.

How do I use it?

▾
You insert it into the vagina once a day at bedtime for three nights in a row. The cream comes with an applicator, and the suppository is one insert. The cream is not for the mouth or eyes, so follow your label's directions.

What side effects should I expect?

▾
Headache is the most common. Some people have genital burning or itching, painful periods or belly pain. These are usually the things to mention at your next visit if they bother you.

When should I stop and call someone?

▾
Stop and call your doctor if you get skin irritation, fever, chills or flu-like symptoms with the cream. Get emergency help for signs of a severe allergic reaction or severe skin peeling and blistering.

Can I use it if I take birth control pills?

▾
Yes. The label says birth control pills do not change how well terconazole works. Hormone levels also did not change significantly in a study with the cream.

Is it safe in pregnancy or while breastfeeding?

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There are no good human data to say. Talk with your doctor so you can weigh the benefits and risks together.

Is Terconazole available over the counter?

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No. Terconazole is a prescription medicine: every Terconazole product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Terconazole first available?

▾
The earliest FDA record we hold for Terconazole is from 1987: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Terconazole was first used.

Who makes Terconazole?

▾
6 companies currently list Terconazole products in the FDA's NDC Directory, including A-S Medication Solutions, Sun Pharmaceutical Industries, Inc., E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Terconazole on HelloPharmacist

Detailed data & references for Terconazole Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Terconazole forms and strengths (how it comes)

Terconazole is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Terconazole inactive ingredients by manufacturer.

Vaginal cream or gel

Vaginal
How this form is used
What it may be used for
  • Terconazole vaginal cream is used for the local treatment of vulvovaginal candidiasis.
Important instructions
  • Terconazole vaginal cream is given as one full applicator inserted into the vagina once daily at bedtime for three days in a row.
  • Terconazole vaginal cream is not for oral or ophthalmic (eye) use.
  • If Terconazole vaginal cream gets in the eyes, rinse with clean water or saline and seek medical care if symptoms persist.
Available strengths 2 strengths
16 FDA-listed product records ⓘ

Vaginal insert

Vaginal
How this form is used
What it may be used for
  • Terconazole vaginal suppositories are used for the local treatment of vulvovaginal candidiasis.
Important instructions
  • Terconazole vaginal suppositories are given as one suppository inserted into the vagina once daily at bedtime for three days in a row.
  • Terconazole vaginal suppositories work even during menstruation.
Available strengths 1 strength
8 FDA-listed product records ⓘ

Terconazole on the U.S. market: products, makers and brands

How Terconazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

6 companies list 12 Terconazole product records with the FDA, mostly as vaginal cream or gel, vaginal insert; the earliest marketing or approval year on record is 1987. Brand names on the directory include Terconazole Vaginal Cream 0.8%; the rest are generics.

2
Dose forms ⓘ
6
Labelers (makers, repackagers, distributors)
2
Brand names
12
FDA-listed product records ⓘ
1987
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions33%
Sun Pharmaceutical Industries, Inc.25%
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC17%
Cosette Pharmaceuticals, Inc.8%
NuCare Pharmaceuticals,Inc.8%
Padagis Israel Pharmaceuticals Ltd8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Terconazole is used (Medicaid data)

A general measure of how commonly Terconazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Terconazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

242,416
Medicaid prescriptions filled (Q1–Q4 2025)
$7.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Terconazole prescribed? Of the 1,601 medications we measure, Terconazole ranks #363 by Medicaid prescriptions — more than 77% of them.

Where Terconazole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Terconazole product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 4 mg/mL vaginal cream is the most-dispensed Terconazole product — about 58% of these Medicaid prescriptions.

terconazole 4 MG/ML Vaginal Cream Most dispensed

141,376 Medicaid prescriptions (Q1–Q4 2025) 58% of Terconazole prescriptions shown $4.4M gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313226

terconazole 8 MG/ML Vaginal Cream

90,844 Medicaid prescriptions (Q1–Q4 2025) 37% of Terconazole prescriptions shown $2.7M gross reimbursement (before rebates) ≈ $29 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313227

terconazole 80 MG Vaginal Insert

10,196 Medicaid prescriptions (Q1–Q4 2025) 4% of Terconazole prescriptions shown $676,387 gross reimbursement (before rebates) ≈ $66 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198245

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Terconazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 15 listed Terconazole NDCs with Medicaid activity.

Compare Terconazole products

A representative set of FDA-listed product records for Terconazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Vaginal cream or gel
4 mg/g Vaginal A-S Medication Solutions × 2 listings ANDA View NDC →
8 mg/g Vaginal A-S Medication Solutions NDA View NDC →
8 mg/g Vaginal A-S Medication Solutions ANDA View NDC →
4 mg/g Vaginal E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC ANDA View NDC →
8 mg/g Vaginal E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC NDA View NDC →
8 mg/g Vaginal NuCare Pharmaceuticals,Inc. ANDA View NDC →
4 mg/g Vaginal Sun Pharmaceutical Industries, Inc. ANDA View NDC →
8 mg/g Vaginal Sun Pharmaceutical Industries, Inc. ANDA View NDC →
💊Vaginal insert
80 mg Vaginal Cosette Pharmaceuticals, Inc. ANDA View NDC →
80 mg Vaginal Padagis Israel Pharmaceuticals Ltd ANDA View NDC →
80 mg Vaginal Sun Pharmaceutical Industries, Inc. ANDA View NDC →

Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Terconazole NDCs →

Terconazole recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Terconazole recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Jan 26, 2022 · Terminated · CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
  • Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-… Lots: Batch 1014228A FDA record D-0198-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Terconazole RxCUI 37806 2 dose forms · 3 strengths
  1. Dose form (SCDF) Vaginal Cream RxCUI 379487 In current FDA listings
    Clinical drug / strength (SCD) 4 MG/ML RxCUI 313226 8 MG/ML RxCUI 313227
  2. Dose form (SCDF) Vaginal Insert RxCUI 2109039 In current FDA listings
    Clinical drug / strength (SCD) 80 MG RxCUI 198245

Look up RxCUI 37806 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Terconazole costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Cream · Vaginal 8 mg/g $0.987 per gram NDC details & price history
Cream · Vaginal 4 mg/g $0.552 per gram NDC details & price history
Suppository · Vaginal 80 mg $18.62 each NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Terconazole brand names

Terconazole is sold under one brand name in the FDA directory — Terconazole Vaginal Cream 0.8%. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Terconazole Vaginal Cream 0.8%

Who makes Terconazole: manufacturers and labelers

6 companies list Terconazole products with the FDA. By number of product records, the largest are A-S Medication Solutions, Sun Pharmaceutical Industries, Inc., E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 4 Sun Pharmaceutical Industries, Inc. 3 E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 2 Cosette Pharmaceuticals, Inc. 1 NuCare Pharmaceuticals,Inc. 1 Padagis Israel Pharmaceuticals Ltd 1

Terconazole drug class (RxNorm)

Terconazole belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Triazole derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Terconazole page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 28, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Terconazole.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Terconazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
14
Finished products in the current FDA directory
12
Companies listing them (makers, repackagers, distributors)
6
FDA labeler codes behind them ⓘ
6
Linked representative label ⓘ
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Linked label effective
Jan 28, 2026
Composite sections available
25
Linked SPL Set ID
f59448bd-f730-46d2-a785-c2d6205579ff
Linked SPL Document ID
4b5df750-9341-4786-8e10-b0d6950f37ed
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →