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Terazol

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Terazol 3, Terazol 7

Terazol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Terazol (terconazole) Vaginal Cream or Suppository is used to treat vaginal candida (yeast) infections. It is an antifungal medication. This medication is available in generic form. Common side effects include headache, increased vaginal/urethral burning/itching/pain, or menstrual cramps.

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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Terazol in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Terazol Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, increased vaginal/urethral burning/itching/pain, or menstrual cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The following may be side effects. However, they may also be symptoms of a different or more serious condition (bacterial vaginosis or Pelvic Inflammatory Disease-PID) that may require different treatment. Tell your doctor immediately if any of these unlikely but serious effects occur: flu-like symptoms (including fever/chills), foul-smelling discharge from the vagina, stomach/abdominal pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Terazol (Terconazole)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Terazol FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Terazol 3, Terazol 7 - User Reviews

Terazol 3, Terazol 7 User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Terazol 3, Terazol 7 sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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