Epinephrine
1 mg/mL · Injection, Solution
- Prescription only
- Catecholamine
- Active substance
- Epinephrine
- Made by
- American Regent, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2023-10-01
Not necessarily this product — shortages are reported per presentation. Your pharmacy will know. · Updated 2026-09-22 FDA drug shortages
Catecholamine
- Emergency treatment of allergic reactions (Type 1), including anaphylaxis ( 1.1 ) To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1.2 )
Adults and Children 30 kg (66 lbs) or more :: 0.3 mg to 0.5 mg (0.3 mL to 0.5 mL) intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary ( 2.2 ) o Children 30 kg (66 lbs) or less :
Full directions ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
Epinephrine injection is a non-selective alpha and beta adrenergic agonist indicated for:
- Emergency treatment of allergic reactions (Type 1), including anaphylaxis ( 1.1 ) To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1.2 )
- 1.1 Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
- 1.2 Hypotension associated with Septic Shoc k Epinephrine injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
From the official label · 2023-10-01 · DailyMed
How it works
From this product’s own US prescribing label.
Epinephrine acts on both alpha and beta-adrenergic receptors.
The mechanism of the rise in blood pressure is 3-fold: a direct myocardial stimulation that increases the strength of ventricular contraction (positive inotropic action), an increased heart rate (positive chronotropic action), and peripheral vasoconstriction.
Epinephrine is extensively metabolized with only a small amount excreted unchanged.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-10-01
Do not take it if
None ( 4 ) None ( 4 )
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Anaphylaxis :
- o
- Adults and Children 30 kg (66 lbs) or more :
- 0.3 mg to 0.5 mg (0.3 mL to 0.5 mL) intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary ( 2.2 ) o Children 30 kg (66 lbs) or less :
- 0.01 mg/kg (0.01 mL/kg), up to 0.3 mg (0.3 mL), intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary ( 2.2 ) Hypotension associated with septic shock:
- o Dilute epinephrine in dextrose solution prior to infusion ( 2.3 ) o Infuse epinephrine into a large vein ( 2.3 ) o Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated to achieve desired mean arterial pressure ( 2.3 ) o Wean gradually ( 2.3 ) o See Full Prescribing Information for instructions on dilution and administration of the injection.
- 2.1 General Considerations Inspect visually for particulate matter and discoloration prior to administration; solution should be clear and colorless.
- Do not use if the solution is colored or cloudy, or if it contains particulate matter.
- 2.2 Anaphylaxis Inject epinephrine intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary.
- When administering to a child, to minimize the risk of injection related injury, hold the leg firmly in place and limit movement prior to and during an injection.
- The injection may be repeated every 5 to 10 minutes as necessary.
- For intramuscular administration, use a needle long enough (at least 1/2 inch) to ensure the injection is administered into the muscle.
- Monitor the patient clinically for the severity of the allergic reaction and potential cardiac effects of the drug, and repeat as needed.
- Do not administer repeated injections at the same site, as the resulting vasoconstriction may cause tissue necrosis.
- Adults and Children 30 kg (66 lbs) or more :
- 0.3 to 0.5 mg (0.3 to 0.5 mL) of undiluted epinephrine administered intramuscularly or subcutaneously in the anterolateral aspect of the thigh, up to a maximum of 0.5 mg (0.5 mL) per injection, repeated every 5 to 10 minutes as necessary.
- Monitor clinically for reaction severity and cardiac effects.
- Children less than 30 kg (66 lbs) :
- 0.01 mg/kg (0.01 mL/kg) of undiluted epinephrine administered intramuscularly or subcutaneously in the anterolateral aspect of the thigh, up to a maximum of 0.3 mg (0.3 mL) per injection, repeated every 5 to 10 minutes as necessary.
- Monitor clinically for reaction severity and cardiac effects.
- 2.3 Hypotension associated with Septic Shock Dilute 1 mL (1 mg) of epinephrine from its ampule to 1,000 mL of a 5% dextrose or 5% dextrose and sodium chloride solution to produce a 1 mcg per mL dilution.
- Administration in saline solution alone is not recommended.
- If indicated, administer whole blood or plasma separately.
- Whenever possible, give infusions of epinephrine into a large vein.
- Avoid using a catheter tie-in technique, because the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug.
- Avoid the veins of the leg in elderly patients or in those suffering from occlusive vascular diseases.
- To provide hemodynamic support in septic shock associated hypotension in adult patients, the suggested dosing infusion rate of intravenously administered epinephrine is 0.05 to 2 mcg/kg/min, and is titrated to achieve a desired mean arterial pressure (MAP).
- The dosage may be adjusted periodically, such as every 10 to 15 minutes, in increments of 0.05 to 0.2 mcg/kg/min, to achieve the desired blood pressure goal.
- After hemodynamic stabilization, wean incrementally over time, such as by decreasing doses of epinephrine every 10 minutes to determine if the patient can tolerate gradual withdrawal.
- Epinephrine diluted in 5% dextrose solutions or 5% dextrose and sodium chloride solutions are stable for 4 hours at room temperature or 24 hours under refrigerated conditions.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Do not inject into buttocks, digits, hands, or feet ( 5.1 )
- Avoid extravasation into tissues, which can cause local necrosis ( 5.3 ) May aggravate angina pectoris or produce ventricular arrhythmias ( 5.7 )
- 5.1 Incorrect Locations of Injection For Anaphylaxis Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate location for administration because of its location, size, and available blood flow.
- Injection into (or near) smaller muscles, such as in the deltoid, is not recommended.
- Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis.
- Do not inject into buttock.
- Injection into the buttock may not provide effective treatment of anaphylaxis and has been associated with the development of Clostridial infections (gas gangrene).
- Do not inject into digits, hands, or feet.
- Epinephrine is a strong vasoconstrictor.
- Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area and tissue necrosis.
- 5.2 Serious Infections at the Injection Site Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis.
- Extravasation and Tissue Necrosis with Intravenous Infusion
- Avoid extravasation of epinephrine into the tissues, to prevent local necrosis.
- When Adrenalin is administered intravenously, check the infusion site frequently for free flow.
- Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage.
- This also may progress on rare occasions to superficial slough.
- Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside.
- There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein.
- Antidote for Extravasation Ischemia :
- To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine , an adrenergic blocking agent.
- Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance.
- Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours.
- 5.4 Hypertension Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to
- avoid excessive increases in blood pressure.
- Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine.
- 5.5 Pulmonary Edema Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema.
- 5.6 Renal Impairment Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment.
- 5.7 Cardiac Arrhythmias and Ischemia Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy.
- 5.8 Allergic Reactions Associated with Sulfite This product does not contain sodium bisulfite.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Risk Summary Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, do not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
- However, there are risks to the mother and fetus associated with epinephrine use during labor or delivery (see Clinical Considerations) .
- In animal reproduction studies, epinephrine administered by the subcutaneous route to pregnant rabbits, mice, and hamsters, during the period of organogenesis, resulted in adverse developmental effects (including gastroschisis, and embryonic lethality, and delayed skeletal ossification) at doses approximately 2 times the maximum recommended daily intramuscular, subcutaneous, or intravenous dose (see Data).
- The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
- All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
- In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
- Clinical Considerations Disease-associated maternal and/or embryo/fetal risk During pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate.
- The prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries.
- Management of anaphylaxis during pregnancy is similar to management in the general population.
- Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients.
- In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care.
- Hypotension associated with septic shock is a medical emergency in pregnancy which can be fatal if left untreated.
- Delaying treatment in pregnant women with hypotension associated with septic shock may increase the risk of maternal and fetal morbidity and mortality.
- Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of epinephrine on the fetus.
- Labor or Delivery Epinephrine usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labor.
- Avoid epinephrine during the second stage of labor.
- In dosage sufficient to reduce uterine contractions, the drug may cause a prolonged period of uterine atony with hemorrhage.
- Avoid epinephrine in obstetrics when maternal blood pressure exceeds 130/80 mmHg.
- Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia.
- Data Animal Data In an embryofetal development study with pregnant rabbits dosed during the period of organogenesis (on days 3 to 5, 6 to 7 or 7 to 9 of gestation), epinephrine caused teratogenic effects (including gastroschisis) at doses approximately 15 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days).
- Animals treated on days 6 to 7 had decreased number of implantations.
- In an embryofetal development study, pregnant mice were administered epinephrine (0.1 to 10 mg/kg/day) on Gestation Days 6 to 15.
- Teratogenic effects, embryonic lethality, and delays in skeletal ossification were observed at approximately 3 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days).
- These effects were not seen in mice at approximately 2 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).
- In an embryofetal development study with pregnant hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine produced reductions in litter size and delayed skeletal ossification at doses approximately 2 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day).
- IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally ( 8.1, 8.5 ) Pregnancy:
- May cause fetal harm ( 8.1 )
- 8.1 Pregnancy Risk Summary Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, do not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
- However, there are risks to the mother and fetus associated with epinephrine use during labor or delivery (see Clinical Considerations) .
- In animal reproduction studies, epinephrine administered by the subcutaneous route to pregnant rabbits, mice, and hamsters, during the period of organogenesis, resulted in adverse developmental effects (including gastroschisis, and embryonic lethality, and delayed skeletal ossification) at doses approximately 2 times the maximum recommended daily intramuscular, subcutaneous, or intravenous dose (see Data).
- The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
- All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
- In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
- Clinical Considerations Disease-associated maternal and/or embryo/fetal risk During pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate.
- The prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries.
- Management of anaphylaxis during pregnancy is similar to management in the general population.
- Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients.
- In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care.
- Hypotension associated with septic shock is a medical emergency in pregnancy which can be fatal if left untreated.
- Delaying treatment in pregnant women with hypotension associated with septic shock may increase the risk of maternal and fetal morbidity and mortality.
- Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of epinephrine on the fetus.
- Labor or Delivery Epinephrine usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labor.
- Avoid epinephrine during the second stage of labor.
- In dosage sufficient to reduce uterine contractions, the drug may cause a prolonged period of uterine atony with hemorrhage.
- Avoid epinephrine in obstetrics when maternal blood pressure exceeds 130/80 mmHg.
- Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia.
- Data Animal Data In an embryofetal development study with pregnant rabbits dosed during the period of organogenesis (on days 3 to 5, 6 to 7 or 7 to 9 of gestation), epinephrine caused teratogenic effects (including gastroschisis) at doses approximately 15 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days).
- Animals treated on days 6 to 7 had decreased number of implantations.
- In an embryofetal development study, pregnant mice were administered epinephrine (0.1 to 10 mg/kg/day) on Gestation Days 6 to 15.
- Teratogenic effects, embryonic lethality, and delays in skeletal ossification were observed at approximately 3 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days).
- These effects were not seen in mice at approximately 2 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).
- In an embryofetal development study with pregnant hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine produced reductions in litter size and delayed skeletal ossification at doses approximately 2 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day).
- 8.2 Lactation Risk Summary There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production.
- However, due to its poor oral bioavailability and short half-life, epinephrine exposure is expected to be very low in the breastfed infant.
- Epinephrine is the first-line medication of choice for treatment of anaphylaxis; it should be used in the same manner for anaphylaxis in breastfeeding and non-breastfeeding patients.
- 8.4 Pediatric Use Clinical use data support weight-based dosing for treatment of anaphylaxis in pediatric patients, and other reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in
- adults.
- Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established.
- 8.5 Geriatric Use Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects.
- However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine.
- Therefore, for the treatment of anaphylaxis, consider starting with a lower dose to take into account potential concomitant disease or other drug therapy.
- Clinical studies of epinephrine for the treatment of hypotension associated with septic shock did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
- Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
- In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives and ergot alkaloids. ( 7.1 ) Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, quinidine and certain antihistamines. ( 7.2 ) Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, and cardiac glycosides. Observe for development of cardiac arrhythmias. ( 7.3 ) Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. ( 7.4 ) 7.1 Drugs Antagonizing Pressor Effects of Epinephrine
- α-blockers, such as phentolamine
- Vasodilators, such as nitrates
- Diuretics
- Antihypertensives
- Ergot alkaloids
- Phenothiazine antipsychotics 7.2 Drugs Potentiating Pressor Effects of Epinephrine
- Sympathomimetics
- β-blockers, such as propranolol
- Tricyclic anti-depressants
- Monoamine oxidase (MAO) inhibitors
- Catechol-O-methyl transferase (COMT) inhibitors, such as entacapone
- Clonidine
- Doxapram
- Oxytocin 7.3 Drugs Potentiating Arrhythmogenic Effects of Epinephrine Cardiac arrhythmias are more common among patients receiving any of the following drugs [see Warnings and Precautions (5.7) and Adverse Reactions (6)] .
- β-blockers, such as propranolol
- Cyclopropane or halogenated hydrocarbon anesthetics, such as halothane
- Antihistamines
- Thyroid hormones
- Diuretics
- Cardiac glycosides, such as digitalis glycosides
- Quinidine 7.4 Drugs Potentiating Hypokalemic Effects of Epinephrine
- Potassium depleting diuretics
- Corticosteroids
- Theophylline
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients.
- Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation.
- Epinephrine overdosage can also cause transient bradycardia followed by tachycardia and these may be accompanied by potentially fatal cardiac arrhythmias.
- Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm).
- Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block.
- Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported.
- Epinephrine is rapidly inactivated in the body and treatment following overdose with epinephrine is primarily supportive.
- Treatment of pulmonary edema consists of a rapidly acting alpha-adrenergic blocking drug (such as phentolamine mesylate) and respiratory support.
- Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug (such as propranolol).
- If necessary, pressor effects may be counteracted by rapidly acting vasodilators or alpha-adrenergic blocking drugs.
- If prolonged hypotension follows such measures, it may be necessary to administer another pressor drug.
Quoted from the official label, section “Overdosage”.
Use in children
- Clinical use data support weight-based dosing for treatment of anaphylaxis in pediatric patients, and other reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in
- adults.
- Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
- Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects.
- However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine.
- Therefore, for the treatment of anaphylaxis, consider starting with a lower dose to take into account potential concomitant disease or other drug therapy.
- Clinical studies of epinephrine for the treatment of hypotension associated with septic shock did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
- Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
- In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Quoted from the official label, section “Geriatric Use”.
Side effects
- Common adverse reactions to systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties.
- These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism [see Warnings and Precautions ( 5.7 )] .
- The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine.
- Adverse reactions reported in observational trials, case reports, and studies are listed below by body system:
- Cardiovascular :
- angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy and stress cardiomyopathy.
- Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see Warnings and Precautions ( 5.7 )].
- Neurological :
- disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling.
- Psychiatric : anxiety, apprehensiveness, restlessness.
- Other :
- Patients with Parkinson’s disease may experience psychomotor agitation or a temporary worsening of symptoms [see Warnings and Precautions ( 5.7 )] .
- Diabetic patients may experience transient increases in blood sugar.
- Injection into the buttock has resulted in cases of gas gangrene [see Warnings and Precautions ( 5.1 )] .
- Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh [see Warnings and Precautions ( 5.2 )].
- Common adverse reactions to systemically administered epinephrine include anxiety, tremor, weakness, dizziness, sweating, palpitations and pallor ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- Advise patients or their caregivers about common adverse reactions associated with the use of epinephrine including an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety.
- These symptoms and signs usually subside rapidly, especially with rest, quiet and recumbent positioning.
- Warn patients with a good response to initial treatment about the possibility of recurrence of symptoms and instruct patients to obtain proper medical attention
- if symptoms return.
- Warn patients with diabetes that they may develop increased blood glucose levels following epinephrine administration.
- Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis.
- Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site. [see Warnings and Precautions ( 5.2 ) ].
- Manufactured by :
- Cenexi Fontenay-sous-Bois France 94120 For :
- Rev. 10/2023 28068594 ARL Logo
Quoted from the official label, section “Patient Counseling Information”.
Strengths and forms
- FORMS AND STRENGTHS Epinephrine injection:
- clear, colorless solution supplied as 1 mg/1 mL, in a single-dose amber glass ampule. Injection:
- 1 mg/mL, 1 mL single-dose ampule ( 3 )
Quoted from the official label, section “Dosage Forms & Strengths”.
What it looks like and how it is packed
- Each carton contains 10 single-dose ampules containing 1 mg/mL epinephrine injection, USP as a clear, colorless, sterile solution in a 1 mL amber glass ampule.
- NDC 0517-1171-01 1 mL Single-Dose Ampule NDC 0517-1171-10 10 Single-Dose Ampules x 1 mL each Discard unused portion.
- Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] .
- Epinephrine is light sensitive.
- Protect from light and freezing.
- Inspect visually for particulate matter and discoloration prior to administration.
- Do not use the solution if it is colored or cloudy, or if it contains particulate matter.
Quoted from the official label, section “How Supplied”.
What is in it
- Epinephrine injection, USP is a clear, colorless, sterile solution containing 1 mg/mL epinephrine, packaged as 1 mL of solution in a single-dose amber glass ampule for intravenous, intramuscular and subcutaneous use.
- In the 1 mL ampule, each 1 mL of epinephrine solution contains 1 mg epinephrine, 9 mg sodium chloride, hydrochloric acid to adjust pH, and water for injection.
- The pH range is 2.2 to 5.0.
- Epinephrine is a sympathomimetic catecholamine.
- The chemical name of epinephrine is:
- 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2- (methylamino)ethyl]benzyl alcohol.
- The chemical structure of epinephrine is: The molecular weight of epinephrine is 183.2.
- Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.
- Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (28)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 28 of 28
- EpinephrineThis onePrescription onlyAmerican Regent, Inc.No ingredient list on the stored label
- EpinephrinePrescription onlyA-S Medication SolutionsNo ingredient list on the stored label
- EpinephrinePrescription onlyAmerican Regent, Inc.No ingredient list on the stored label
- EpinephrinePrescription onlyAmneal Pharmaceuticals LLCNo ingredient list on the stored label
- EpinephrinePrescription onlyAmneal Pharmaceuticals Private LimitedNo ingredient list on the stored label
- EpinephrinePrescription onlyBaxter Healthcare CorporationSulfites
- EpinephrinePrescription onlyBPI Labs, LLCNo ingredient list on the stored label
- EpinephrinePrescription onlyBPI Labs, LLCNo ingredient list on the stored label
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- EpinephrinePrescription onlyFresenius Kabi USA, LLCNo ingredient list on the stored label
- EpinephrinePrescription onlyGland Pharma LimitedNo ingredient list on the stored label
- EpinephrinePrescription onlyGland Pharma LimitedNo ingredient list on the stored label
- EpinephrinePrescription onlyGLENMARK PHARMACEUTICALS INC., USANo ingredient list on the stored label
- EpinephrinePrescription onlyGLENMARK PHARMACEUTICALS INC., USANo ingredient list on the stored label
- EpinephrinePrescription onlyHenry Schein, Inc.No ingredient list on the stored label
- EpinephrinePrescription onlyHF Acquisition Co LLC, DBA HealthFirstNo ingredient list on the stored label
- EpinephrinePrescription onlyHikma Pharmaceuticals USA Inc.No ingredient list on the stored label
- EpinephrinePrescription onlyInternational Medication Systems, LimitedNo ingredient list on the stored label
- AdrenalinPrescription onlyMedical Purchasing Solutions, LLCNo ingredient list on the stored label
- EpinephrinePrescription onlyMedical Purchasing Solutions, LLCNo ingredient list on the stored label
- EpinephrinePrescription onlyMedical Purchasing Solutions, LLC.No ingredient list on the stored label
- AdrenalinPrescription onlyPar Health USA, LLCNo ingredient list on the stored label
- AdrenalinPrescription onlyProPharma DistributionNo ingredient list on the stored label
- EpinephrinePrescription onlyProPharma DistributionNo ingredient list on the stored label
- AdrenalinPrescription onlyREMEDYREPACK INC.No ingredient list on the stored label
- EpinephrinePrescription onlyREMEDYREPACK INC.No ingredient list on the stored label
- EpinephrinePrescription onlyREMEDYREPACK INC.No ingredient list on the stored label
- Adrenalin VialsPrescription onlySina Health IncNo ingredient list on the stored label
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | American Regent, Inc. |
|---|---|
| Active substance | Epinephrine |
| Strength | 1 mg/mL |
| Form | Injection, Solution |
| Route | Intramuscular; Subcutaneous |
| Packs | 10 AMPULE in 1 BOX / 1 mL in 1 AMPULE |
| NDC | 0517-1171 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
61 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Injection41 products
.15 mg/.15mL4
- 30 mg/30mL
- Injection, Solution, Concentrate11 products
- Injection, Solution8 products
- .1 mg/.1mL
.1 mg/mL2
.1 mg/mL · 2 companies
- .15 mg/.15mL
- .3 mg/.3mL
- 1 mg/mL
- 16 ug/mL
- 64 ug/mL
- Liquid1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.