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Terazol 3, Terazol 7

Last reviewed on RxList: 2/24/2017
Terazol Side Effects Center

Last reviewed on RxList 11/23/2016

Terazol (terconazole) Vaginal Cream or Suppository is an antifungal medication used to treat vaginal candida (yeast) infections. Terazol is available in generic form. Common side effects of Terazol include:

  • headache,
  • increased vaginal/urethral burning/itching/pain, or
  • menstrual cramps.

Tell your doctor if you have unlikely but serious effects of Terazol including:

  • flu-like symptoms (including fever and chills),
  • foul-smelling discharge from the vagina, and
  • stomach or abdominal pain.

One full applicator of Terazol 7 Vaginal Cream (20 mg terconazole) is used intravaginally once daily at bedtime for seven days. One full applicator of Terazol 3 Vaginal Cream (40 mg terconazole) is used intravaginally once daily for three days. One Terazol 3 Vaginal Suppository (80 mg terconazole) is used intravaginally once daily for three days. Terazol may interact with other vaginal creams or douches. Other medications may also interact with Terazol vaginal. Talk to your doctor before taking any prescription or over-the-counter medicines, including herbal products. During pregnancy, Terazol should be used only when prescribed. 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. It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breastfeeding.

Our Terazol (terconazole) Vaginal Cream Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Terazol Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using terconazole vaginal and call your doctor at once if you have a serious side effect such as:

  • severe vaginal burning or irritation; or
  • fever, chills, flu symptoms.

Less serious side effects may include:

  • headache; or
  • menstrual cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Terazol (Terconazole)

Terazol Professional Information

SIDE EFFECTS

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

Read the entire FDA prescribing information for Terazol (Terconazole)

Related Resources for Terazol

Read the Terazol User Reviews »

© Terazol Patient Information is supplied by Cerner Multum, Inc. and Terazol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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