Terazol Side Effects

Generic name: terconazole topical

Note: This document contains side effect information about terconazole topical. Some of the dosage forms listed on this page may not apply to the brand name Terazol.

Some side effects of Terazol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to terconazole topical: vaginal cream, vaginal suppository

Get emergency medical help if you have any of these signs of an allergic reaction while taking terconazole topical (the active ingredient contained in Terazol) 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 of terconazole topical 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.

For Healthcare Professionals

Applies to terconazole topical: vaginal cream, vaginal suppository

Local

Local side effects have been commonly reported. These have involved the genitourinary (occurring in up to 20% of treated patients), and have included burning (up to 15.2%), irritation (3.1%), itching (2.3%), pain, and rash. Drug discontinuation due to adverse effects occurs in 2% to 4% of patients.

Genitourinary

Genitourinary side effects have included dysmenorrhea (6%), vulvovaginal burning (5.2%), genital burning and itching (5%), pain of the female genitalia (4.2%), and vulvovaginal itching (0.7%).

Nervous system

Nervous system side effects have included headache (up to 30.3%).

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (3.4%).

Other

Other side effects have included fever (up to 2.8%), body pain (up to 3.9%), and chills (up to 1.8%). Terconazole topical (the active ingredient contained in Terazol) may rarely be associated with a flu-like syndrome consisting of fever, chills, nausea, and dizziness. One patient also developed leukocytosis and dyspnea.

Dermatologic

During US and foreign clinical trials, photosensitivity reactions were not reported in patients who were treated with terconazole suppositories or vaginal cream (0.4% and 0.8%).

Dermatologic side effects have included photosensitivity reactions following repeated dermal application of 2% and 0.8% creams under conditions of filtered artificial ultraviolet light.

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