FDA label 9f789e65-2050-42ea-9b06-6adee341edd6
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
- fa778759-2b9a-4446-ba06-d3c486019e79
- SPL ID
- 9f789e65-2050-42ea-9b06-6adee341edd6
- Version
- 1
- Effective date
- 2010-04-29
- Source export date
- 2026-10-12
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:33:00
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 | 9f789e65-2050-42ea-9b06-6adee341edd6 | id | |
| spl set id | fa778759-2b9a-4446-ba06-d3c486019e79 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS There is no evidence that mebendazole, even at high doses, is effective for hydatid disease. There have been rare reports of neutropenia and agranulocytosis when mebendazole was taken for prolonged periods and at dosages substantially above those recommended.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Gastrointestinal Transient symptoms of abdominal pain and diarrhea in cases of massive infection and expulsion of worms. Hypersensitivity Rash, urticaria and angioedema have been observed on rare occasions. Central Nervous System Very rare cases of convulsions have been reported. Liver There have been liver function test elevations [AST (SGOT), ALT (SGPT), and GGT] and rare reports of hepatitis when mebendazole was taken for prolonged periods and at dosages substantially above those recommended. Hematologic Neutropenia and agranulocytosis. (See WARNINGS ).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.