Note: This document contains side effect information about terconazole topical. Some dosage forms listed on this page may not apply to the brand name Terazol 7.

Applies to terconazole topical: vaginal cream, vaginal suppository.

Serious side effects of Terazol 7

Along with its needed effects, terconazole topical (the active ingredient contained in Terazol 7) 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 while taking terconazole topical:

More common

• Burning feeling in the vagina

Less common

• Chills
• fever
• itching or irritation in the vagina

Incidence not known

• 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

Other side effects of Terazol 7

Some side effects of terconazole topical 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:

More common

• Cramps
• headache
• heavy bleeding
• pain

Less common

• Abdominal or stomach pain
• body pain

Incidence not known

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

For Healthcare Professionals

Applies to terconazole topical: vaginal cream, vaginal suppository.

Nervous system

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]

Very common (10% or more): Headache (up to 30.3%)

Postmarketing reports: Dizziness^[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]