What the label lists and what reports show
Terconazole side effects
Terconazole's FDA label lists its adverse reactions in its own words. FAERS holds 822 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (95 reports).
- Generic listed
Check it at the source: the terconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAdverse Reactions from Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole 0.4% vaginal cream. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole 0.4% vaginal cream were headache (26% vs. 17% with placebo) and body pain (2.1% vs. 0% with placebo). Fever (1.7% vs. 0.5% with placebo) and chills (0.4% vs. 0.0% with placebo), vulvovaginal burning, itching and irritation have also been reported. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Terconazole Vaginal Cream 0.8% label published by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC of January 28, 2026; the label quoted above does not print one.
| Reaction | Terconazole Vaginal Cream, 0.8% n=231 (%) | Terazol ® 3 n=229 (%) |
|---|---|---|
| Headache | 49 (21) | 37(16) |
| Dysmenorrhea | 14 (6) | 5 (2) |
| Genital Burning and Itching | 12 (5) | 15-21 (6-9) |
| Abdominal Pain | 8 (3.4) | 2 (1) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set 10e84353-93d2-461d-8b79-e9294df047ae), via openFDA; the full label on DailyMed
What do FAERS reports show?
822 reports list terconazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 169 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Terconazole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions