warnings
WARNINGS None.
FDA label 8d38d308-d218-4f4e-b7bf-e29acb3a8c56
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
- 6ad06079-bc6f-4dcb-b684-82fbe3a8cb5d
- SPL ID
- 8d38d308-d218-4f4e-b7bf-e29acb3a8c56
- Version
- 1
- Effective date
- 2009-08-28
- Source export date
- 2026-11-06
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:41:34
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 | 8d38d308-d218-4f4e-b7bf-e29acb3a8c56 | id | |
| spl set id | 6ad06079-bc6f-4dcb-b684-82fbe3a8cb5d | 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 of therapy 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.