FDA label 0b21df55-d223-4ea8-8c20-71fe6dbd566d

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
b1ae8ce5-b05e-429a-a425-541892d8a464
SPL ID
0b21df55-d223-4ea8-8c20-71fe6dbd566d
Version
2
Effective date
2006-07-27
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:35:52

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

adverse reactions

ADVERSE REACTIONS Certain signs and symptoms have been reported in association with the use of this drug but, in these instances, it is often impossible to determine the relationship of the underlying disease and drug administration to the reported reaction. Such reactions include maculopapular erythema, increase in blood pressure, paresthesia, malaise, aches and edema of the extremities, glossitis, anorexia and nausea and vomiting. Alopecia alone and with associated nail growth disturbance have been reported rarely; these side effects subsided without interruption of treatment.

Reported adverse events (FAERS/openFDA)#

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