Terconazole Side Effects

Brand Names: Terazol 3, Terazol 7, Zazole

Please note - some side effects for Terconazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Terconazole - for the Consumer

Terconazole Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Terconazole Cream:

Body pain; burning or itching of the vagina; painful menstruation; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; flu-like symptoms (headache; tiredness; muscle aches; fever); vaginal sensitivity or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Terconazole Suppositories

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Terconazole Suppositories:

Body pain; burning or itching of the vagina; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; flu-like symptoms (headache; tiredness; muscle aches; fever); vaginal sensitivity or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Terconazole Side Effects - for the Professional

Terconazole

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% v. 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).

Side Effects by Body System - for Healthcare Professionals

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 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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