warnings
WARNINGS None.
FDA label 7d3e640f-1255-494d-b7dd-609eb47414d0
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
- 2de0f965-fba6-43a3-a3d8-9740349df6a7
- SPL ID
- 7d3e640f-1255-494d-b7dd-609eb47414d0
- Version
- 104
- Effective date
- 2026-01-29
- Source export date
- 2026-10-12
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:27:46
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 | 7d3e640f-1255-494d-b7dd-609eb47414d0 | id | |
| spl set id | 2de0f965-fba6-43a3-a3d8-9740349df6a7 | 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, patients with vulvovaginal candidiasis were treated with terconazole vaginal cream 0.8% for 3 days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole vaginal cream 0.8% were headache (21% vs 16% with placebo) and dysmenorrhea (6% vs 2% with placebo). Genital complaints in general, and burning and itching in particular, occurred less frequently in the terconazole vaginal cream 0.8% 3 day regimen (5% vs. 6%-9% with placebo). Other adverse experiences reported with terconazole vaginal cream 0.8% were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs. 0.3% with placebo). The therapy-related dropout rate was 2.0% for the terconazole vaginal cream 0.8%. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole vaginal cream 0.8% group and 0.3% with the placebo group.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.