warnings
WARNINGS: None.
FDA label a9696f80-0921-464e-914b-6a933baee7b9
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
- b5aa5021-2a1b-4d21-a6b0-821ea1f9e2d0
- SPL ID
- a9696f80-0921-464e-914b-6a933baee7b9
- Version
- 3
- Effective date
- 2019-03-04
- Source export date
- 2026-10-12
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:01:30
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 | a9696f80-0921-464e-914b-6a933baee7b9 | id | |
| spl set id | b5aa5021-2a1b-4d21-a6b0-821ea1f9e2d0 | 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, 284 patients with vulvovaginal candidiasis were treated with terconazole vaginal suppositories 80 mg. Based on comparative analyses with placebo (295 patients), the adverse experiences considered adverse reactions most likely related to terconazole vaginal suppositories 80 mg, were headache (30.3% vs.20.7% with placebo) and pain of the female genitalia (4.2% vs. 0.7% with placebo). Adverse reactions that were reported but were not statistically significantly different from placebo were burning (15.2% vs. 11.2% with placebo) and body pain (3.9% vs. 1.7% with placebo). Fever (2.8% vs. 1.4% with placebo) and chills (1.8% vs. 0.7% with placebo) have also been reported. The therapy-related dropout rate was 3.5% and the placebo therapy-related dropout rate was 2.7%. The adverse drug experience on terconazole most frequently causing discontinuation was burning (2.5% vs 1.4% with placebo) and pruritus (1.8% vs. 1.4% with placebo).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.