warnings
WARNINGS None.
FDA label 21f4c243-27a0-4342-b919-856a6b5686b0
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- 145fd419-cb5b-48d3-ad6c-ca0e474c9d50
- SPL ID
- 21f4c243-27a0-4342-b919-856a6b5686b0
- Version
- 6
- Effective date
- 2019-02-15
- Source export date
- 2026-10-12
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:47:35
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 21f4c243-27a0-4342-b919-856a6b5686b0 | id | |
| spl set id | 145fd419-cb5b-48d3-ad6c-ca0e474c9d50 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole vaginal cream 0.4%. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole vaginal cream 0.4% were headache (26% vs 17% with placebo) and body pain (2.1% vs 0% with placebo). Vulvovaginal burning (5.2%), itching (2.3%) or irritation (3.1%) occurred less frequently with terconazole vaginal cream 0.4% than with the vehicle placebo. Fever (1.7% vs 0.5% with placebo) and chills (0.4% vs 0.0% with placebo) have also been reported. The therapy-related dropout rate was 1.9%. The adverse drug experience on terconazole most frequently causing discontinuation was vulvovaginal itching (0.6%), which was lower than the incidence for placebo (0.9%).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.