FDA label 8d3fe84c-fa54-4603-acde-29d34cb5fa2d

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
1925eb50-747f-46de-828d-49bdb038fe83
SPL ID
8d3fe84c-fa54-4603-acde-29d34cb5fa2d
Version
2
Effective date
2006-10-06
Source export date
2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:11:38

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Patients who have early Leber’s disease (hereditary optic nerve atrophy) have been found to suffer severe and swift optic atrophy when treated with vitamin B 12 . Fatal hypokalemia may occur when severe megaloblastic anemia is treated intensively with vitamin B 12 , as a result of increased erythrocyte potassium requirements (see PRECAUTIONS, Laboratory Tests ). Anaphylactic shock and death have been reported after parenteral vitamin B 12 administration. An intradermal test dose is recommended before cyanocobalamin is administered to patients suspected of being sensitive to this drug. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS No serious toxic reactions have been reported following the intramuscular administration of cyanocobalamin. The following allergic-type reactions have been reported rarely; the relationship of these reactions to cyanocobalamin or other components in the preparation is unknown. Generalized —anaphylactic shock and death have been reported with administration of parenteral vitamin B 12 (see WARNINGS ) Cardiovascular —pulmonary edema and congestive heart failure early in treatment, peripheral vascular thrombosis Hematologic —polycythemia vera Gastrointestinal —mild transient diarrhea Dermatologic —itching, transitory exanthema, urticaria Miscellaneous —feeling of swelling of entire body

Reported adverse events (FAERS/openFDA)#

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