FDA label fc5891b3-77bb-49e7-b4c2-38fa7a983e9c
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
- 070d391a-0525-4172-add9-5cb45e0c5d67
- SPL ID
- fc5891b3-77bb-49e7-b4c2-38fa7a983e9c
- Version
- 6
- Effective date
- 2019-10-16
- Source export date
- 2026-09-28
- 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/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:23:00
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 | fc5891b3-77bb-49e7-b4c2-38fa7a983e9c | id | |
| spl set id | 070d391a-0525-4172-add9-5cb45e0c5d67 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: Administer with caution to elderly people; to those with cardiovascular disease, hypertension, diabetes, or hyperthyroidism; in psychoneurotic individuals; and in pregnancy. Patients with long-standing bronchial asthma and emphysema who have developed degenerative heart disease should be administered the drug with extreme caution. Overdosage or inadvertent intravenous injection of epinephrine may cause cerebrovascular hemorrhage resulting from the sharp rise in blood pressure. (See OVERDOSAGE ) Fatalities may also result from pulmonary edema because of the peripheral constriction and cardiac stimulation produced. Rapidly acting vasodilators, such as nitrites, or alpha blocking agents may counteract the marked pressor effects of epinephrine. Epinephrine contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic rather than in non-asthmatic people. Epinephrine is the preferred treatment of serious allergic or other emergency situations even though this product contains sodium metabisulfite, a sulfite that may in other products cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons. The alternative to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations. Cardiovascular effects: Inadvertently induced high arterial blood pressure may result in angina pectoris (especially when coronary insufficiency is present), or aortic rupture. Epinephrine may induce potentially serious cardiac arrhythmias in patients not suffering from heart disease and patients with organic heart disease or who are receiving drugs that sensitize the myocardium. With Epinephrine, a paradoxical but transient lowering of blood pressure, bradycardia and apnea may occur immediately after injection. Cerebrovascular hemorrhage: Overdosage or inadvertent I.V. injection of epinephrine may cause cerebrovascular hemorrhage resulting from the sharp rise in blood pressure. Pulmonary edema: Fatalities may also result from pulmonary edema because of the peripheral constriction and cardiac stimulation produced.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Transient and minor side effects of anxiety, headache, fear, and palpitations often occur with therapeutic doses, especially in hyperthyroid individuals. Repeated local injections can result in necrosis at sites of injection from vascular constriction. “Epinephrine-fastness” can occur with prolonged use. Local: Repeated local injections can result in necrosis at sites of injection from vascular constriction. Systemic: Cerebral hemorrhage; hemiplegia; subarachnoid hemorrhage; anginal pain in patients with angina pectoris; anxiety; restlessness; throbbing headache; tremor; weakness; dizziness; pallor; respiratory difficulty; palpitation; apprehensiveness; sweating; nausea; vomiting.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.