Zazole

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.

Terconazole is a prescription medication used to treat vaginal yeast infections. Terconazole belongs in a class of antifungal medications called azoles. These work by slowing the growth of fungi and yeast that cause infection.

This medication comes in a cream or suppository to be inserted into the vagina and is usually used once daily at bedtime for 3 or 7 consecutive days. 

Common side effects of terconazole include headache, painful menstrual periods, and vaginal burning and itching.

Terconazole is an antifungal medication that fights infections caused by fungus.

Terconazole vaginal (for use in the vagina) is used to treat vaginal Candida (yeast) infections.

Terconazole vaginal may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

It is not likely that other drugs you take orally or inject will have an effect on terconazole used in the vagina. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Burning feeling in the vagina

• Chills
• fever
• itching or irritation in the vagina

• Blistering, peeling, or loosening of the skin
• chills
• cough
• diarrhea
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever
• general feeling of discomfort or illness
• headache
• hives or welts
• hoarseness
• irritation
• itching
• joint or muscle pain
• joint pain, stiffness or swelling
• loss of appetite
• muscle aches and pains
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin
• runny nose
• shivering
• skin rash
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• trouble sleeping
• troubled breathing
• unusual tiredness or weakness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Cramps
• headache
• heavy bleeding
• pain

• Abdominal or stomach pain
• body pain

• Difficulty with moving
• lack or loss of strength
• muscle aching or cramping
• muscle pain or stiffness
• swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Zazole® Vaginal Suppositories (terconazole vaginal suppositories, 80 mg) are white to off-white suppositories for intravaginal administration containing 80 mg of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, in triglycerides derived from coconut and/or palm kernel oil (a base of hydrogenated vegetable oils) and butylated hydroxyanisole.

The structural formula of terconazole is as follows:

Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.

One Zazole® Vaginal Suppository (terconazole vaginal suppositories, 80 mg) should be administered intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of terconazole vaginal suppositories is not affected by menstruation.

Applies to terconazole topical: vaginal cream, vaginal suppository

Nervous system

Very common (10% or more): Headache (up to 30.3%)
Postmarketing reports: Dizziness[Ref]

Headache was reported in 26%, 21%, and 30.3% of patients using the 0.4% vaginal cream, 0.8% vaginal cream, and vaginal suppositories, respectively. In clinical trials with the suppository, headache occurred in up to 20.7% of patients given placebo.[Ref]

Local

The suppository formulation was discontinued most often due to burning and pruritus.[Ref]

Frequency nor reported: Pain, rash

Vaginal suppositories:
-Very common (10% or more): Burning (15.2%)
-Common (1% to 10%): Pruritus[Ref]

Genitourinary

The cream formulations were discontinued most often due to vulvovaginal itching.[Ref]

Vaginal cream 0.4%:
-Frequency not reported: Vulvovaginal burning/itching/irritation

Vaginal cream 0.8%:
-Common (1% to 10%): Dysmenorrhea, genital burning and itching
-Frequency not reported: Vulvovaginal itching

Vaginal suppositories:
-Common (1% to 10%): Pain of the female genitalia[Ref]

Other

Frequency not reported: Influenza-like illness (consisting of fever, chills, nausea, dizziness)
Postmarketing reports: Asthenia, influenza-like illness (consisting of multiple reactions including fever, chills, nausea, vomiting, myalgia, arthralgia, malaise), face edema

Vaginal cream 0.4%
-Common (1% to 10%): Body pain, fever
-Uncommon (0.1% to 1%): Chills

Vaginal cream 0.8%
-Uncommon (0.1% to 1%): Fever

Vaginal suppositories
-Common (1% to 10%): Body pain, fever, chills[Ref]

Gastrointestinal

Vaginal cream 0.8%:
-Common (1% to 10%): Abdominal pain[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity, anaphylaxis[Ref]

Dermatologic

Photosensitivity reactions were reported after repeated dermal application of 2% and 0.8% cream formulations under conditions of filtered artificial ultraviolet light. During US and foreign clinical trials, photosensitivity reactions were not reported in patients who were treated with the suppositories or vaginal cream (0.4% and 0.8%).[Ref]

Frequency not reported: Photosensitivity reactions
Postmarketing reports: Rash, toxic epidermal necrolysis, urticaria[Ref]

Respiratory

Frequency not reported: Dyspnea
Postmarketing reports: Bronchospasm[Ref]

At least 1 patient developed leukocytosis and dyspnea.[Ref]

Hematologic

At least 1 patient developed leukocytosis and dyspnea.[Ref]

Frequency not reported: Leukocytosis[Ref]

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