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
- 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
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 8d3fe84c-fa54-4603-acde-29d34cb5fa2d | id | |
| spl set id | 1925eb50-747f-46de-828d-49bdb038fe83 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.