warnings
WARNING Clotrimazole lozenges are not indicated for the treatment of systemic mycoses including systemic candidiasis.
FDA label abf93477-f551-4e30-ba94-b2981a9d90cd
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
- eacf7456-5f44-483d-8b5f-c2c273f46e76
- SPL ID
- abf93477-f551-4e30-ba94-b2981a9d90cd
- Version
- 2
- Effective date
- 2009-10-22
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:04:38
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 | abf93477-f551-4e30-ba94-b2981a9d90cd | id | |
| spl set id | eacf7456-5f44-483d-8b5f-c2c273f46e76 | 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 Abnormal liver function tests have been reported in patients treated with clotrimazole lozenges; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See Precautions section). Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the lozenge.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.