FDA-filed SPL labeling · retrieved through openFDA

Terconazole

Terconazole is an antifungal medication used vaginally to treat vulvovaginal candidiasis (vaginal yeast infections).

Brand name Terconazole Vaginal Cream 0.8%
Drug class Azole Antifungal
Rx Forms 2 Route Vaginal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 27, 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 →

At a glance
Linked label effectiveJan 28, 2026
Clinical labels in scope 14
AvailabilityRx
Earliest approval/marketing year 1987
FDA-listed product records 32
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 15, 2026
Terconazole at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Terconazole is a vaginal antifungal used to treat yeast infections caused by Candida, available as a cream or suppository and typically used once nightly for three days. It works well for this specific type of infection, but stop use and contact your doctor if you develop skin irritation, fever, chills, or any sign of a serious allergic reaction. Because it only targets Candida, your diagnosis should be confirmed before or during treatment.

📖 Terconazole: Patient Information Guide

A plain-language walkthrough of Terconazole — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Terconazole is an antifungal used vaginally to treat yeast infections. It is available in two forms — vaginal cream and vaginal suppositories — and both are approved for the same condition:

  • Vulvovaginal candidiasis (a vaginal yeast infection caused by Candida species) — treated with both terconazole vaginal cream and terconazole vaginal suppositories

Because terconazole only works against Candida, a diagnosis should be confirmed by lab testing (KOH smear and/or cultures) before or during treatment. For suppositories, the diagnosis must be re-confirmed before any second course of treatment.

⚙️How it works

Terconazole belongs to a class of drugs called azole antifungals. It works by blocking a specific enzyme — called 14 alpha-lanosterol demethylase — that Candida fungi need to produce ergosterol, a key building block of their cell walls. When this step is blocked, abnormal sterols build up and ergosterol is depleted, causing the fungal cell wall to fail. This stops the fungus from growing and spreading.

Human cells use a similar but less sensitive version of this enzyme, which is why terconazole targets the fungus without causing the same damage to your own cells. In lab testing, terconazole did not significantly affect beneficial Lactobacillus bacteria normally found in the vagina.

💊How it's taken

Terconazole is used vaginally — never swallowed or applied to the eyes. Both the cream and suppository forms are used once daily at bedtime.

  • Terconazole vaginal cream: one full applicator inserted vaginally at bedtime for 3 consecutive days
  • Terconazole vaginal suppositories: one suppository inserted vaginally at bedtime for 3 consecutive days

Always follow your prescriber's specific instructions. If you miss a dose, follow the guidance on your product label or ask your pharmacist.

🤒Side effects — in detail

The most common side effects reported with terconazole include:

  • Headache
  • Genital burning and itching
  • Painful periods (dysmenorrhea)
  • Abdominal pain
  • Fever (reported in less than 2% of patients)

Stop use immediately and call your doctor if you experience skin irritation, fever, chills, or flu-like symptoms — or if you notice any signs of a serious allergic reaction such as swelling, hives, or difficulty breathing.

⚠️Warnings & precautions
  • Skin irritation or flu-like symptoms: Stop terconazole and do not repeat treatment if these develop during use — they may signal a reaction to the medication.
  • Serious allergic reactions: Rare cases of anaphylaxis (a severe, life-threatening allergic response) and toxic epidermal necrolysis (widespread, severe skin blistering) have been reported with terconazole suppositories. Stop use immediately and seek emergency care if these occur.
  • Known allergy: Do not use terconazole if you are allergic to it or any ingredient in the product.
  • Azole allergy history: If you've had reactions to other azole antifungals, tell your doctor — cross-sensitivity is not fully understood, so monitoring is advised.
🔀What it interacts with

Based on available information, terconazole has limited known drug interactions when used vaginally:

  • Oral contraceptives: Terconazole does not reduce the effectiveness of birth control pills, and birth control pills do not reduce terconazole's antifungal effect — hormone levels (estradiol and progesterone) were not significantly changed in studies.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Allergy to terconazole: Do not use if you have a known allergy to terconazole or any component of the product.
  • Azole allergy history: Tell your doctor if you've ever reacted to other azole antifungals — your doctor may want to monitor you.
  • Pregnancy: Human safety data in pregnancy are limited. Animal studies showed no malformations at doses relevant to vaginal use, but higher oral doses caused developmental effects in animals. Talk to your doctor before using during pregnancy.
  • Breastfeeding: It is not known if terconazole passes into breast milk. Discuss the benefits and risks with your doctor.
  • Children: Safety and effectiveness in female pediatric patients have not been established.
  • Adults 65 and older: Clinical studies did not include enough older adults to determine if they respond differently — use with the guidance of a healthcare provider.
🚑If you take too much

Terconazole vaginal products are not meant to be swallowed. If the cream or suppository is accidentally ingested, supportive and symptomatic care should be provided — contact Poison Control or seek medical help right away. If the cream gets into the eyes, rinse thoroughly with clean water or saline and seek medical attention if irritation or symptoms continue.

📡Pharmacodynamics — effects in the body

Terconazole works directly at the site of infection in the vagina. When applied vaginally, most of the dose stays in the local vaginal tissue — about 70% of a suppository dose remains in the vaginal area during the retention period. This local concentration is what fights the Candida infection, while only a small fraction (around 5–16%) enters the bloodstream. Beneficial vaginal bacteria (Lactobacillus species) are not significantly affected because they require much higher concentrations of terconazole to be inhibited.

🔬Pharmacokinetics — how your body processes it

After vaginal application, terconazole is absorbed slowly and to a limited extent — roughly 5–16% depending on the individual. Peak blood levels occur about 5 to 10 hours after application and remain very low. The drug is highly protein-bound (about 95%) in the bloodstream, meaning most of it attaches to blood proteins rather than circulating freely. Once absorbed, terconazole is extensively broken down (metabolized) by the body, and the unchanged drug has an elimination half-life of roughly 6 to 8.5 hours. It is cleared from the body through both urine and feces.

📦How to store it

Store at 20° to 25°C (68° to 77°F) .

📄 Written from Terconazole’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. 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.

🩺 Pharmacist Counseling Corner

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 exactly is terconazole used for?
Terconazole treats vaginal yeast infections — specifically those caused by a fungus called Candida. It comes as a vaginal cream or a vaginal suppository, and both work the same way: fighting the yeast right at the source. Because it only works against Candida, your doctor should confirm that's what's causing your symptoms before or during treatment.
How do I use it, and how long does treatment last?
You insert terconazole vaginally — either using the applicator with the cream or inserting the suppository — once each night at bedtime for three nights in a row. It is not taken by mouth and should not be used in your eyes. Stick to the three-day course even if you start feeling better sooner, and follow your product's label instructions closely.
What side effects should I expect, and which ones mean I should stop?
The most common side effects are headache, genital burning or itching, painful periods, and abdominal discomfort. These are generally manageable. However, if you develop skin irritation, fever, chills, or flu-like symptoms while using terconazole, stop using it right away and call your doctor — those could be signs of a reaction. Rare but serious allergic reactions, including severe skin blistering, have been reported. If you notice hives, swelling, or difficulty breathing, seek emergency care immediately.
Can I use terconazole if I'm on birth control pills?
Yes — terconazole does not interfere with the effectiveness of oral contraceptives, and the pill doesn't reduce how well terconazole works. Hormone levels were not meaningfully changed in studies, so you don't need to worry about your birth control failing while using this medication.
Is it safe to use during my period?
For the vaginal suppository form, the label specifically notes that menstruation does not affect how well it works — so you can continue treatment through your period if needed. Follow your prescriber's guidance on timing.
Can I use terconazole if I'm pregnant or breastfeeding?
If you're pregnant, talk to your doctor before using terconazole. Human pregnancy data are limited, and while animal studies didn't show birth defects at doses comparable to vaginal use, your doctor needs to weigh the benefits and risks for your specific situation. If you're breastfeeding, it's also worth a conversation with your provider — we don't currently know whether terconazole passes into breast milk.
Is Terconazole available over the counter?
Terconazole is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Terconazole first available?
Terconazole has been available in the United States since at least 1987, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Terconazole?
Terconazole is supplied by 13 manufacturers listed in the FDA NDC Directory, including A-S Medication Solutions, Padagis Israel Pharmaceuticals Ltd, RPK Pharmaceuticals, Inc..

💬 Answers drafted from Terconazole’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Terconazole 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.

Vaginal cream or gel

Vaginal
How this form is used
What it may be used for
  • Terconazole vaginal cream is used to treat vulvovaginal candidiasis (vaginal yeast infection caused by Candida)
Important instructions
  • Terconazole vaginal cream is administered intravaginally using an applicator once daily at bedtime for three consecutive days
  • Terconazole vaginal cream is not for oral or ophthalmic (eye) use
  • If accidentally applied to the eyes, rinse with clean water or saline and seek medical attention if symptoms persist
Available strengths 2 strengths
21 FDA-listed product records

Vaginal insert

Vaginal
How this form is used
What it may be used for
  • Terconazole vaginal suppositories are used to treat vulvovaginal candidiasis (vaginal yeast infection caused by Candida)
Important instructions
  • Terconazole vaginal suppositories are inserted intravaginally once daily at bedtime for three consecutive days
  • Terconazole vaginal suppositories can be used during menstruation — the therapeutic effect is not affected by your period
  • Before starting another course of Terconazole vaginal suppository treatment, the diagnosis should be re-confirmed by lab tests
Available strengths 1 strength
8 FDA-listed product records

📊 Terconazole across the U.S. market

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.

2
Dose forms
13
Manufacturers
2
Brand names
32
FDA-listed product records
1987
First marketed

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 Solutions19%
Padagis Israel Pharmaceuticals Ltd13%
RPK Pharmaceuticals, Inc.13%
Sun Pharmaceutical Industries, Inc.9%
Taro Pharmaceuticals U.S.A., Inc.9%
Cosette Pharmaceuticals, Inc.6%
Other makers31%

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

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 1,594 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.)

Showing 32 of 32 products — FDA National Drug Code Directory. See every product, package size and price: browse all 32 Terconazole NDCs →

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.

🏷️ Sold under these brand names

Terconazole Vaginal Cream 0.8%

🏭 Manufacturers & labelers

A-S Medication Solutions 6 Padagis Israel Pharmaceuticals Ltd 4 RPK Pharmaceuticals, Inc. 4 Sun Pharmaceutical Industries, Inc. 3 Taro Pharmaceuticals U.S.A., Inc. 3 Cosette Pharmaceuticals, Inc. 2 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 2 E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 2 NuCare Pharmaceuticals,Inc. 2 Bryant Ranch Prepack 1 Derivados Quimicos 1 Quimica Sintetica S.A. 1 W. R. Grace & Co.-Conn. 1

RxNorm drug class

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.

🔬 Where this comes from

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
NDC products indexed
32
Distinct labelers/manufacturers represented
13
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 ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 14 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.