FDA label 19019f2e-1487-4da6-a664-d0bcfbe9d78e

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
ad040924-85c4-4bcb-b73a-1d599d81154b
SPL ID
19019f2e-1487-4da6-a664-d0bcfbe9d78e
Version
2
Effective date
2010-10-29
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:55

Warnings cross-check#

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warnings

WARNINGS Studies on the teratogenicity of pyrazole compounds in animals have yielded inconclusive results. Up to the present time, however, there have been no reported cases of human congenital malformation proved to be due to the use of the drug. It is suggested that Anturane be used with caution in pregnant women, weighing the potential risks against the possible benefits.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The most frequently reported adverse reactions with Anturane have been upper gastrointestinal disturbances. In these patients it is advisable to administer the drug with food, milk, or antacids. Despite this precaution, Anturane may aggravate or reactivate peptic ulcer. Rash has been reported. In most instances, this reaction did not necessitate discontinuance of therapy. In general, Anturane has not been observed to affect electrolyte balance. Blood dyscrasias (anemia, leukopenia, agranulocytosis, thrombocytopenia, and aplastic anemia) have rarely been reported. There has also been a published report associating Anturane, administered concomitantly with other drugs including colchicine, with leukemia following long-term treatment of patients with gout. However, the circumstances involved in the two cases reported are such that a cause-and-effect relationship to Anturane has not been clearly established.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.