Side Effects of Terazol (terconazole)

Terazol (terconazole) is an antifungal cream and suppository used to treat vaginal yeast infections (Candida). It prevents growth of yeast by preventing production of the membranes that surround the yeast cells. 

Common side effects of Terazol include:

• irritation, and
• increased sensitivity and burning of the vulva or vagina. 

Other side effects of Terazol include:

• headache,
• painful menstrual periods,
• aches,
• abdominal pain,
• fever,
• chills, and
• itching.

There are no known drug interactions with Terazol. 

Tell your doctor if you are pregnant before using Terazol; it is unknown how it might affect a fetus. Pregnant women should use extra care when using the vaginal applicator. The Canadian manufacturer does not recommend using this product during the first 3 months of pregnancy. 

Consult your doctor before breastfeeding.

The most common side effects associated with terconazole are:

• irritation,
• increased sensitivity and burning of the vulvae or vagina.

Other side effects include:

• headache,
• painful menstrual periods,
• aches,
• abdominal pain,
• fever,
• chills, and
• itching.

Clinical Trials

Terazol 7 (terconazole) Vaginal Cream 0.4%

During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole 0.4% vaginal cream. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole 0.4% vaginal cream were:

• headache (26% vs. 17% with placebo) and
• body pain (2.1% vs. 0% with placebo).

Vulvovaginal burning (5.2%), itching (2.3%) or irritation (3.1%) occurred less frequently with terconazole 0.4% vaginal cream than with the vehicle placebo.

Fever (1.7% vs. 0.5% with placebo) and chills (0.4% vs. 0.0% with placebo) have also been reported.

The therapy-related dropout rate was 1.9%. The adverse drug experience on terconazole most frequently causing discontinuation was vulvovaginal itching (0.6%), which was lower than the incidence for placebo (0.9%).

Terazol 3 (terconazole) Vaginal Cream 0.8%

During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole 0.8% vaginal cream for three days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole 0.8% vaginal cream were headache (21% vs. 16% with placebo) and dysmenorrhea (6% vs. 2% with placebo).

Genital complaints in general, and burning and itching in particular, occurred less frequently in the terconazole 0.8% vaginal cream 3 day regimen (5% vs. 6%-9% with placebo). Other adverse experiences reported with terconazole 0.8% vaginal cream were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs. 0.3% with placebo).

The therapy-related dropout rate was 2.0% for the terconazole 0.8% vaginal cream. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole 0.8% vaginal cream group and 0.3% with the placebo group.

Terazol 3 (terconazole) Vaginal Suppositories 80 mg

During controlled clinical studies conducted in the United States, 284 patients with vulvovaginal candidiasis were treated with terconazole 80 mg vaginal suppositories. Based on comparative analyses with placebo (295 patients), the adverse experiences considered adverse reactions most likely related to terconazole 80 mg vaginal suppositories were headache (30.3% vs. 20.7% with placebo) and pain of the female genitalia (4.2% vs. 0.7% with placebo).

Adverse reactions that were reported but were not statistically significantly different from placebo were burning (15.2% vs. 11.2% with placebo) and body pain (3.9% vs. 1.7% with placebo). Fever (2.8% vs. 1.4% with placebo) and chills (1.8% vs. 0.7% with placebo) have also been reported.

The therapy-related dropout rate was 3.5% and the placebo therapy-related dropout rate was 2.7%. The adverse drug experience on terconazole most frequently causing discontinuation was burning (2.5% vs. 1.4% with placebo) and pruritus (1.8% vs. 1.4% with placebo).

Post-marketing Experience

The following adverse drug reactions have been first identified during post-marketing experience with Terazol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General: Asthenia, Influenza-Like Illness consisting of multiple listed reactions including fever and chills, nausea, vomiting, myalgia, arthralgia, malaise

Immune: Hypersensitivity, Anaphylaxis, Face Edema

Nervous: Dizziness

Respiratory: Bronchospasm

Skin: Rash, Toxic Epidermal Necrolysis, Urticaria

Terazol 7 (terconazole) Vaginal Cream 0.4% and Terazol® 3 (terconazole) Vaginal Suppositories 80 mg

The therapeutic effect of these products is not affected by oral contraceptive usage.

Terazol 3 (terconazole) Vaginal Cream 0.8%

The levels of estradiol (E2) 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.