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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.