FDA label e65b78b4-21b6-4966-b8da-2dd42d077777

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
9880b900-ea23-11dc-ad56-0002a5d5c51b
SPL ID
e65b78b4-21b6-4966-b8da-2dd42d077777
Version
11
Effective date
2019-06-26
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 01:35:22

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 Clinical experience with ADAGEN ® (pegademase bovine) Injection has been limited. The following adverse reactions were reported: headache in one patient and pain at the injection site in two patients. The following adverse reactions have been identified during post-approval use of ADAGEN ® (pegademase bovine) Injection. Because these reactions are reported voluntarily from a very small population, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hematologic events: hemolytic anemia, auto-immune hemolytic anemia, thrombocythemia, thrombocytopenia and autoimmune thrombocytopenia. Dermatological events: injection site erythema, urticaria. Lymphomas To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or by email at drugsafety@leadiant.com or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch .

Reported adverse events (FAERS/openFDA)#

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