Terconazole
Cream · Vaginal
Uses
Terconazole Vaginal Cream, is indicated for the treatment of vulvovaginal candidiasis in adult females. Terconazole Vaginal Cream is an azole antifungal indicated for the treatment of vulvovaginal candidiasis in adult females. ( 1 )
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 )
Dosage forms and strengths
Terconazole Vaginal Cream, 0.8% contains 8mg terconazole per gram of cream. Each measured dose applicator delivers 5 grams of cream containing 40 mg of terconazole. Vaginal cream containing terconazole 0.8%: supplied in a 20 gram tube with a measured dose applicator. Each applicator delivers 40 mg of terconazole. ( 3 )
Contraindications
Terconazole Vaginal Cream, 0.8% is contraindicated in patients with known hypersensitivity to terconazole or to any of the components of the cream. Known hypersensitivity to terconazole or any other component of the cream ( 4 )
Warnings and precautions
Risk of Skin Irritation and Flu-Like Symptoms: Discontinue Terconazole Vaginal Cream and do not retreat if skin irritation, fever, chills or flu-like symptoms are reported during use. ( 5 ) 5.1 Risk of Skin Irritation and Flu-Like Symptoms Discontinue Terconazole Vaginal Cream and do not retreat, if skin irritation, fever, chills or flu-like symptoms are reported during use. 5.2 Hypersensitivity There is no information regarding cross-hypersensitivity between terconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.
Side effects
Most common adverse reactions (incidence ≥ 2%) were headache, dysmenorrhea, genital burning and itching, and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fougera at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and estimating their relative rates. 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 ≥2% of Patients Receiving Terconazole Vaginal Cream in a Randomized, Double-Blind Active Controlled Trial Terconazole Vaginal Cream, 0.8% n=231 (%) Terazol ® 3 n=229 (%) Headache 49 (21) 37(16) Dysmenorrhea 14 (6) 5 (2) Genital Burning and Itching 12 (5) 15-21 (6-9) Abdominal Pain 8 (3.4) 2 (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%).
Drug interactions
Oral Contraceptives: There is no known interaction with the concomitant use of this product and oral contraceptives.
Use in specific populations
8.1 Pregnancy 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 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. 8.4 Pediatric Use The safety and effectiveness of Terconazole Vaginal Cream have not been established in female pediatric patients for the treatment of vulvovaginal candidiasis. 8.5 Geriatric Use Clinical studies of Terconazole Vaginal Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Pregnancy
8.1 Pregnancy 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.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of Terconazole Vaginal Cream have not been established in female pediatric patients for the treatment of vulvovaginal candidiasis.
Geriatric use
8.5 Geriatric Use Clinical studies of Terconazole Vaginal Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Overdosage
Overdosage of terconazole in humans has not been reported to date.
Description
Terconazole Vaginal Cream, 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis -1-[ p [[2-(2,4-Dichlorophenyl)-2-(1 H -1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4- yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows: Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol. chemical-structure
Mechanism of action
12.1 Mechanism of Action Terconazole is an antifungal agent [see Microbiology ( 12.4 )] .
How supplied
Terconazole Vaginal Cream 0.8% is supplied in a 20-gram tube with a measured dose applicator. NDC 0168-0347-20 Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Patient information
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. Important Administration Instructions Inform patients using Terconazole Vaginal Cream, 0.8% of the following important administration instructions:
• Terconazole Vaginal Cream, 0.8% is for intravaginal use only. Avoid contact with eyes and inside the nose and mouth.
• Terconazole Vaginal Cream, 0.8% should be used for three days as directed, even if you feel better quickly.
• Do not use this Terconazole Vaginal Cream for any disorder other than the one for which it was prescribed.
• Terconazole Vaginal Cream, 0.8% should be used once a day as directed.
• If your sexual partner has itching, redness or discomfort in the genital area, tell your partner to consult a physician and that you are being treated for a yeast infection.
• Terconazole Vaginal Cream, 0.8% can be used during a menstrual period but external pads should be used until the medication treatment has been completed. Tampons may absorb the medication and should not be used. You may wish to wear an absorbent panty liner while using Terconazole Vaginal Cream, 0.8%.
• Don’t scratch the vaginal area. Scratching can cause more irritation and spread the infection.
• Wash hands before and after applying Terconazole Vaginal Cream, 0.8%. Inform patients who are prone to vaginal yeast infections of the following additional instructions:
• Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast.
• Wipe from front to rear (away from the vagina) after a bowel movement.
• Don’t douche unless the healthcare provider specifically tells you to do so. Douching may disturb the balance of normal bacterial flora and the pH of secretions. The brands listed are the registered trademarks of their respective owners and are not trademarks of Fougera Pharmaceuticals Inc. Manufactured by: E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747
Label text from the FDA structured product label by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC (revised Jan 28, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Terconazole in 12 products
Terconazole NDC products (12)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-0917 | Terconazole 4 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-1196 | Terconazole 8 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-6266 | Terconazole 4 mg/g Cream | A-S Medication Solutions | ANDA |
| 0713-0552 | Terconazole 80 mg/1 Suppository | Cosette Pharmaceuticals, Inc. | ANDA |
| 0168-0346 | Terconazole 4 mg/g Cream | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 68071-1626 | Terconazole 8 mg/g Cream | NuCare Pharmaceuticals,Inc. | ANDA |
| 45802-717 | Terconazole 80 mg/1 Suppository | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 51672-1302 | Terconazole 8 mg/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1304 | Terconazole 4 mg/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1330 | Terconazole 80 mg/1 Suppository | Sun Pharmaceutical Industries, Inc. | ANDA |
| 50090-6299 | Terconazole 8 mg/g Cream | A-S Medication Solutions | NDA |
| 0168-0347 | Terconazole 8 mg/g Cream | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | NDA |
Terconazole recalls
- D-0198-2024 Jan 3, 2024 · Class II · Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Frequently asked questions
What is Terconazole used for?
Terconazole Vaginal Cream, is indicated for the treatment of vulvovaginal candidiasis in adult females. Terconazole Vaginal Cream is an azole antifungal indicated for the treatment of vulvovaginal candidiasis in adult females. ( 1 )
What are the side effects of Terconazole?
Most common adverse reactions (incidence ≥ 2%) were headache, dysmenorrhea, genital burning and itching, and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fougera at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical… See the full label for the complete list.
Who makes Terconazole?
Terconazole is listed by 6 labelers in the FDA NDC directory, including A-S Medication Solutions, Cosette Pharmaceuticals, Inc., E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NuCare Pharmaceuticals,Inc..
Has Terconazole been recalled?
The FDA enforcement database lists 1 recall for Terconazole, most recently D-0198-2024 (class ii): CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.