Applies to terconazole topical: vaginal cream, vaginal suppository.
Serious side effects of Terconazole topical
Along with its needed effects, terconazole topical 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 Terconazole topical
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]
