FDA-filed SPL labeling · retrieved through openFDA

Secnidazole

Secnidazole is an antibiotic used to treat bacterial vaginosis and trichomoniasis in patients 12 years of age and older.

Brand name Solosec
Drug class Nitroimidazole Antimicrobial
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 1 clinical label set 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 effectiveFeb 19, 2025
AvailabilityRx
Earliest approval/marketing year 2010
FDA-listed product records 9
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 17, 2026
Secnidazole at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Secnidazole (Solosec) is a one-time oral antibiotic dose that effectively treats bacterial vaginosis and trichomoniasis in patients 12 and older. The most important practical steps are to avoid all alcohol for at least 2 days after your dose and, if you have trichomoniasis, to make sure your sexual partner is treated at the same time. Watch for signs of a vaginal yeast infection as a possible side effect, and contact your doctor if one develops.

📖 Secnidazole: Patient Information Guide

A plain-language walkthrough of Secnidazole — 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

Secnidazole is an antibiotic used to treat specific vaginal and sexually transmitted infections in patients 12 years of age and older.

  • Solosec oral powder is approved to treat bacterial vaginosis in female patients aged 12 and older — a condition caused by an overgrowth of certain bacteria in the vagina.
  • Solosec oral powder is approved to treat trichomoniasis — a sexually transmitted infection caused by the parasite Trichomonas vaginalis — in patients aged 12 and older. Because trichomoniasis passes between partners, sexual partners should be treated simultaneously.
  • Solosec should only be used for infections that are confirmed or strongly suspected to require this type of antibiotic. Using it unnecessarily increases the risk of drug-resistant bacteria.
⚙️How it works

Secnidazole is a nitroimidazole antimicrobial. Drugs in this class penetrate bacterial and parasitic cells and interfere with their DNA, essentially preventing the organisms from replicating and causing them to die off. This targeted mechanism helps eliminate the bacteria responsible for bacterial vaginosis and the parasite responsible for trichomoniasis.

To protect the effectiveness of secnidazole and other antibiotics, it should only be used when there is a confirmed or strongly suspected need — overuse of antibiotics can allow drug-resistant organisms to develop.

💊How it's taken

Solosec oral powder is taken as a single one-time oral dose — no multi-day course is required. The granules are sprinkled onto a soft food (applesauce, yogurt, or pudding) and eaten within 30 minutes, without chewing or crunching. It can be taken with or without food, and at any time of day. For trichomoniasis, sexual partners must take the same dose at the same time.

  • Do not dissolve Solosec granules in any liquid.
  • Avoid all alcohol and products containing ethanol or propylene glycol during treatment and for at least 2 days after your dose.
  • Because this is a single-dose treatment, there is no missed-dose scenario — but follow your prescriber's instructions if you are unsure.
🤒Side effects — in detail

The most common side effects reported with Solosec include:

  • Vaginal yeast infection (vulvovaginal candidiasis) — the most frequently reported side effect
  • Nausea
  • Headache
  • Diarrhea
  • Abdominal pain
  • Vaginal itching (vulvovaginal pruritus)
  • Vomiting
  • Altered taste (dysgeusia)

Contact your doctor if you develop signs of a vaginal yeast infection — itching, irritation, or unusual discharge — as it may need to be treated with an antifungal. Seek immediate care if you have symptoms of a severe allergic reaction such as rash, difficulty breathing, or facial swelling.

⚠️Warnings & precautions
  • Vaginal yeast infection: Solosec can trigger a yeast infection (vulvovaginal candidiasis). It occurred in about 1 in 10 women in bacterial vaginosis trials. Let your doctor know if symptoms appear — an antifungal may be needed.
  • Cockayne syndrome — do not use: Solosec is contraindicated in people with Cockayne syndrome. A closely related drug, metronidazole, has caused severe and rapidly fatal liver failure in these patients. If you or a family member has this condition, alert your prescriber immediately.
  • Potential cancer risk with long-term use: Related drugs have caused tumors in animals given high, chronic doses. A single dose as prescribed is unlikely to carry this risk, but chronic or repeated use should be avoided.
  • Drug resistance: Using Solosec when it is not clearly needed contributes to antibiotic resistance. Only use it as directed for a confirmed or strongly suspected infection.
🔀What it interacts with

There are two key interactions to know about with Solosec:

  • Alcohol (and ethanol/propylene glycol-containing products): Drinking alcohol or using products containing these substances while taking Solosec — or within 2 days after — can cause nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache. Avoid all alcohol during this window.
  • Combination oral contraceptives (such as ethinyl estradiol plus norethindrone): No clinically significant interaction was found. These can be taken together without concern about reduced contraceptive effectiveness based on available data.

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
  • Tell your doctor if you have ever had an allergic reaction to secnidazole or any other nitroimidazole drug (such as metronidazole or tinidazole).
  • Do not take Solosec if you have Cockayne syndrome — a related drug has caused fatal liver failure in people with this rare condition.
  • If you are pregnant or thinking about becoming pregnant, discuss the risks with your doctor — available data in pregnant women are too limited to confirm safety.
  • Do not breastfeed during treatment or for 96 hours (4 days) after your dose. You may pump and discard milk during that time and feed your baby stored milk or formula instead.
  • Safety and effectiveness have been established in patients aged 12 and older. Solosec has not been studied in children under 12.
  • Older adults (65+) were not included in large numbers in clinical trials — let your doctor know your full medical history so they can assess whether it is appropriate for you.
📡Pharmacodynamics — effects in the body

The exact relationship between secnidazole blood levels and its therapeutic effect has not been fully established. Studies did show that higher secnidazole concentrations were associated with a small lengthening of the QTc interval (a measure of heart electrical activity), but no clinically meaningful change in heart rhythm was seen even at doses three times the standard amount.

🔬Pharmacokinetics — how your body processes it

After a single oral dose of Solosec taken with applesauce, secnidazole is absorbed and reaches peak blood levels in about 4 hours. Blood levels gradually decline over the following days, dropping significantly by 96 hours — which is why breastfeeding is paused for that length of time. Food does not meaningfully affect how much of the drug is absorbed, whether the dose is taken fasted or with a high-fat meal. The drug distributes widely throughout the body, with a volume of distribution of approximately 42 liters.

📦How to store it

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

📄 Written from Secnidazole’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 →

46

Supplements & herbs that interact with Secnidazole

46 supplements and herbal products have documented interactions with Secnidazole 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 · 35
  • Minor · 10
Every supplement checked against Secnidazole — ranked by severity The full interaction hub: 1 major · 35 moderate · 10 minor · every one linked to its full report. Check Secnidazole 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.

7

Nutrient depletion considerations

Secnidazole has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 6
  • Moderate · 1
See the full Secnidazole nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. 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 Secnidazole — the kind of thing our pharmacy team would talk through with you at the counter.

Do I really only need one dose, or do I have to take this for several days?
Yes — Solosec is genuinely a one-time, single-dose treatment. You take the entire packet once, mixed into a soft food, and that's it. There's no multi-day course to remember or finish. That said, your symptoms may take a little time to fully resolve, so follow up with your doctor if things don't improve.
Can I drink alcohol after taking it?
You'll want to skip alcohol completely — not just during the dose, but for at least 2 full days afterward. Mixing secnidazole with alcohol can cause an unpleasant reaction: nausea, vomiting, stomach pain, dizziness, and headache. This includes alcoholic drinks, certain mouthwashes, and any products that list ethanol or propylene glycol as ingredients. It's only a couple of days, so it's worth being careful.
How exactly do I take this powder?
Tear open the packet at the corner marked with an arrow, then sprinkle all of the granules onto a spoonful of applesauce, yogurt, or pudding. Eat the entire mixture within 30 minutes. The key thing is not to chew or crunch the granules — swallow them whole. You can drink a glass of water afterward to help wash them down. Don't stir the granules into a drink; they're not meant to dissolve in liquid.
I have trichomoniasis. Does my partner need to be treated too?
Yes, absolutely. Trichomoniasis is a sexually transmitted infection, so if only one partner is treated, you're likely to pass it back and forth. Your sexual partner needs to take the same dose at the same time you do. Make sure they speak with a healthcare provider to get their own prescription.
Is it normal to get a yeast infection after taking this?
It does happen — a vaginal yeast infection was the most common side effect in clinical trials, occurring in roughly 1 in 10 women treated for bacterial vaginosis. If you notice increased itching, irritation, or an unusual discharge in the days after your dose, let your doctor know. A yeast infection is very treatable with an antifungal, but it won't go away on its own.
Can I take this if I'm breastfeeding?
Breastfeeding isn't recommended while taking Solosec or for 96 hours — that's 4 full days — after your dose. The drug stays in your system for several days, and because the effects on a nursing baby aren't known, the recommendation is to pause breastfeeding during that window. You can pump and discard your milk to keep up your supply, and feed your baby stored breast milk or formula in the meantime. After 96 hours, it's generally safe to resume.
Is Secnidazole available over the counter?
Secnidazole 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 Secnidazole first available?
Secnidazole has been available in the United States since at least 2010, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Secnidazole?
Secnidazole is supplied by 8 manufacturers listed in the FDA NDC Directory, including Corden Pharma Bergamo S.p.A., Catalent Pharma Solutions, LLC, Darmerica, Llc.

💬 Answers drafted from Secnidazole’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 Secnidazole comes

Secnidazole is available in 1 form. 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.

Oral powder

By mouth
Brands Solosec
How this form is used
What it may be used for
  • Solosec is used to treat bacterial vaginosis in female patients aged 12 and older
  • Solosec is used to treat trichomoniasis caused by Trichomonas vaginalis in patients aged 12 and older
Important instructions
  • Solosec: open the packet, sprinkle all of the granules onto applesauce, yogurt, or pudding, and eat the entire mixture within 30 minutes
  • Solosec: swallow the granules without chewing or crunching them — a glass of water afterward can help
  • Solosec: do not dissolve the granules in any liquid
  • Solosec: avoid alcohol and products containing ethanol or propylene glycol during treatment and for at least 2 days after your dose
Available strengths 1 strength
2 FDA-listed product records

📊 Secnidazole across the U.S. market

How Secnidazole 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.

1
Dose forms
8
Manufacturers
1
Brand names
9
FDA-listed product records
2010
First marketed

Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Corden Pharma Bergamo S.p.A.22%
Catalent Pharma Solutions, LLC11%
Darmerica, Llc11%
Evofem Inc.11%
Hunan Jiudian Pharmaceutical Co.,Ltd.11%
Lupin Pharmaceuticals, Inc.11%
Other makers22%

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

📈 How widely Secnidazole is used

A general measure of how commonly Secnidazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q2–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Secnidazole 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.

374
Medicaid prescriptions filled (Q2–Q4 2025)
$110,338 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Secnidazole prescribed? Of the 1,596 medications we measure, Secnidazole ranks #1,392 by Medicaid prescriptions — more than 13% of them.

Where Secnidazole ranks among the drugs we measure · Q2–Q4 2025 · neighbors ±5

Utilization by Secnidazole 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.

secnidazole 2000 MG Oral Granules

374 Medicaid prescriptions (Q2–Q4 2025) 100% of Secnidazole prescriptions shown $110,338 gross reimbursement (before rebates) ≈ $295 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1946692

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 Secnidazole, 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 1 of 2 listed Secnidazole NDCs with Medicaid activity.

🔍 Compare Secnidazole products

A representative set of FDA-listed product records for Secnidazole — 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
💊Oral powder
2 g/4.8 g Oral Evofem Inc. NDA View NDC →
2 g/4.8 g Oral Lupin Pharmaceuticals, Inc. NDA View NDC →
💊Bulk drug substance
2 g/4.8 g Catalent Pharma Solutions, LLC DRUG FOR FURTHER PROCESSING View NDC →
1 kg/kg Corden Pharma Bergamo S.p.A. × 2 listings BULK INGREDIENT View NDC →
5000 g/5000 g Darmerica, Llc BULK INGREDIENT View NDC →
1 kg/kg Hunan Jiudian Pharmaceutical Co.,Ltd. BULK INGREDIENT View NDC →
1 g/g Qingdao Biopeptek Co., Ltd. BULK INGREDIENT View NDC →
1 kg/kg Zhejiang Supor Pharmaceuticals Co., Ltd BULK INGREDIENT View NDC →

Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Secnidazole 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) Secnidazole RxCUI 36314 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Granules RxCUI 1946691 In current FDA listings
    Clinical drug / strength (SCD) 2000 MG RxCUI 1946692

Look up RxCUI 36314 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

Solosec

🏭 Manufacturers & labelers

Corden Pharma Bergamo S.p.A. 2 Catalent Pharma Solutions, LLC 1 Darmerica, Llc 1 Evofem Inc. 1 Hunan Jiudian Pharmaceutical Co.,Ltd. 1 Lupin Pharmaceuticals, Inc. 1 Qingdao Biopeptek Co., Ltd. 1 Zhejiang Supor Pharmaceuticals Co., Ltd 1

RxNorm drug class

Secnidazole belongs to the Nitroimidazole Antimicrobial class.

Pharmacologic class Nitroimidazole Antimicrobial
Drug family (ATC) Nitroimidazole 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 Feb 19, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Secnidazole.
📈
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 Secnidazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
9
Distinct labelers/manufacturers represented
8
Linked representative label
Evofem Inc.
Linked label effective
Feb 19, 2025
Composite sections available
23
Linked SPL Set ID
056485b6-8bba-4a21-ae00-cdb4e7ae4bfa
Linked SPL Document ID
4a3aa8e8-bb23-46ce-998d-69dc7c9fb386
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set 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. Evofem 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.