Oteseconazole: uses, dosing, side effects & brands
Oteseconazole is an azole antifungal sold in the U.S. under one brand, for vulvovaginal candidiasis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Azole Antifungal
- Treats
- Vulvovaginal Candidiasis
- Available as
- Capsule
- Sold as
- Vivjoa
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
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How oteseconazole is dosed
From the FDA label for Vivjoa (application NDA215888). Other oteseconazole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
There are two recommended VIVJOA dosage regimens: a VIVJOA-only regimen and a Fluconazole/VIVJOA regimen. Use one of these two dosage regimens. ( 2.1 ) Administer VIVJOA orally with food. ( 2.1 ) For the VIVJOA-only Dosage Regimen : ( 2.2 ) On Day 1: Administer VIVJOA 600 mg (as a single dose), then On Day 2: Administer VIVJOA 450 mg (as a single dose), then Beginning on Day 14 : Administer VIVJOA 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 through 12). For the Fluconazole/VIVJOA Dosage Regimen , prescribe fluconazole and: ( 2.3 ) On Day 1 , Day 4 , and Day 7 : Administer fluconazole 150 mg orally, then On Days 14 through 20 : Administer VIVJOA 150 mg once daily for 7 days, then Beginning on Day 28 : Administer VIVJOA 150 mg once a week (every 7 days) for 11 weeks (Weeks 4 through 14). 2.1 Dosage Overview and Important Administration Instructions There are two recommended VIVJOA dosage regimens: a VIVJOA-only regimen and a Fluconazole/ VIVJOA regimen. Use one of the following two dosage regimens: VIVJOA-only dosage regimen [see Dosage and Administration (2.2) ] Fluconazole/VIVJOA dosage regimen [see Dosage and Administration (2.3) ] . Administer VIVJOA orally with food [see Clinical Pharmacology (12.3) ]. Swallow the capsules whole. Do not chew, crush, dissolve, or open the capsules. 2.2 VIVJOA-only Dosage Regimen For the VIVJOA-only dosage regimen: On Day 1:…
Oteseconazole side effects
The most frequently reported adverse reactions (incidence > 2%) were headache and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 580 patients were treated with VIVJOA in three clinical trials (Trial 1, Trial 2, and Trial 3) [see Clinical Studies (14) ] . Patients in the clinical trials were women with RVVC who received VIVJOA treatment for 12 weeks. The mean age of the patient population was 34 years (range:16-78 years), with 84% of patients aged 18-44 years and 16% of patients aged 45 years and older. Although females of reproductive potential were included in the clinical safety data, VIVJOA is contraindicated in females of reproductive potential due to the risk of embryo-fetal toxicity [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3 , 8.4) ] . The clinical trials population was 75% (435/580) White, 17% (96/580) Black or African American, 6% (36/580) Asian, and 2% (13/580) Other women. Fifteen percent…
Who shouldn’t take oteseconazole
VIVJOA is contraindicated in: Females of reproductive potential [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] Pregnant and lactating women [see Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.2) ] Patients with known hypersensitivity to oteseconazole. Females of Reproductive Potential ( 4 ), ( 5.1 ), ( 8.3 ) Pregnant and Lactating women ( 4 ), ( 8.1 ), ( 8.2 ) Hypersensitivity to oteseconazole ( 4 )
Oteseconazole drug interactions
BCRP (Breast Cancer Resistance Protein) Substrates: Concomitant use of VIVJOA with BCRP substrates may increase the exposure of drugs that are BCRP substrates, which may increase the risk of adverse reactions associated with these drugs. Use the lowest possible starting dose of the BCRP substrate or consider reducing the dose of the substrate drugs and monitor for adverse reactions. ( 7.1 ) 7.1 Effect of VIVJOA on Other Drugs BCRP (Breast Cancer Resistance Protein) Transporter Substrates Oteseconazole is a BCRP inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates (e.g., rosuvastatin), which may increase the risk of adverse reactions associated with these drugs. Use the lowest possible starting dose of the BCRP substrate or consider reducing the dose of the substrate drug and monitor for adverse reactions [see Clinical Pharmacology (12.3) ] .
Every oteseconazole product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Vivjoa.
What oteseconazole pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| OTE;150 | 150 mg | purple | capsule | — |
Can you crush or split oteseconazole?
At least one oteseconazoleproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each oteseconazole label says about crushing, splitting and chewingRelated calculators
Frequently asked questions
What is oteseconazole?
VIVJOA (oteseconazole capsules) contains oteseconazole which is an oral azole antifungal agent.
What kind of drug is oteseconazole?
The FDA classifies oteseconazole as an azole antifungal. Azole antifungals block a fungal enzyme (lanosterol 14-alpha-demethylase) that the fungus needs to make ergosterol, a key building block of its cell membrane. Without enough ergosterol the membrane becomes leaky and unstable, which stops the fungus from growing and can cause it to break apart and die. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take oteseconazole with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run oteseconazole against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does oteseconazole come in?
Across the brands we track, oteseconazole is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic oteseconazole?
We do not currently list a generic-labelled oteseconazole product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Oteseconazole: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/oteseconazole
- MLA
- “Oteseconazole: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/oteseconazole.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for oteseconazole on DailyMed (NIH) ↗.