Terconazole topical Side Effects

Some side effects of terconazole topical 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

Other dosage forms:

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

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

Seek medical attention right away if any of these SEVERE side effects occur while taking terconazole topical:

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

For Healthcare Professionals

Applies to terconazole topical: vaginal cream, vaginal suppository

Local

The suppository formulation was discontinued most often due to burning (2.5%) and pruritus (1.8%).

Common (1% to 10%): Local genitourinary side effects (including burning [up to 15.2%], irritation [3.1%], itching/pruritus [2.3%])
Frequency not reported: Pain, rash

Genitourinary

Common (1% to 10%): Dysmenorrhea (6%), vulvovaginal burning (5.2%), genital burning and itching (5%), pain of the female genitalia (4.2%), vulvovaginal itching

The cream formulations were discontinued most often due to vulvovaginal itching (up to 0.7%).

Nervous system

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

Other

Common (1% to 10%): Body pain (up to 3.9%), fever (up to 2.8%), chills (up to 1.8%)
Rare (less than 0.1%): Influenza-like syndrome (consisting of fever, chills, nausea, dizziness)
Postmarketing reports: Asthenia, influenza-like illness (consisting of multiple reactions including fever and chills, nausea, vomiting, myalgia, arthralgia, malaise)

Gastrointestinal

Common (1% to 10%): Abdominal pain (3.4%)

Dermatologic

Photosensitivity reactions were reported after repeated dermal application of terconazole 2% and 0.8% creams under conditions of filtered artificial ultraviolet light. 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%).

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

Hypersensitivity

Postmarketing reports: Hypersensitivity, anaphylaxis, face edema

Hematologic

At least 1 patient developed leukocytosis and dyspnea.

Rare (less than 0.1%): Leukocytosis (at least 1 case)

Respiratory

Rare (less than 0.1%): Dyspnea (at least 1 case)
Postmarketing reports: Bronchospasm

At least 1 patient developed leukocytosis and dyspnea.

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